D.N. Bernstein, Office of Medical Education, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA J.R. Houck, Department of Physical Therapy, George Fox University, Newberg, OR, USA B. Mahmood, W.C. Hammert, Department of Orthopaedics and Rehabilitation, University of Rochester Medical Center, Rochester, NY, USA.
Clin Orthop Relat Res. 2019 Nov;477(11):2544-2551. doi: 10.1097/CORR.0000000000000773.
The Patient-reported Outcome Measurement Information System (PROMIS) continues to be an important universal patient-reported outcomes measure (PROM) in orthopaedic surgery. However, there is concern about the performance of the PROMIS as a general health questionnaire in hand surgery compared with the performance of region- and condition-specific PROMs such as the Michigan Hand Questionnaire (MHQ) and the Boston Carpal Tunnel Questionnaire (BCTQ), respectively. To ensure that PROMIS domains capture patient-reported outcomes to the same degree as region- and condition-specific PROMs do, comparing PROM performance is necessary.
QUESTIONS/PURPOSES: (1) Which PROMs demonstrate high responsiveness among patients undergoing carpal tunnel release (CTR)? (2) Which of the PROMIS domains (Physical Function [PF], Upper Extremity [UE], and Pain Interference [PI]) demonstrate concurrent validity with the HHQ and BCTQ domains?
In this prospective study, between November 2014 and October 2016, patients with carpal tunnel syndrome visiting a single surgeon who elected to undergo CTR completed the BCTQ, MHQ, and PROMIS UE, PF, and PI domains at each visit. A total of 101 patients agreed to participate. Of these, 31 patients (31%) did not return for a followup visit at least 6 weeks after CTR and were excluded, leaving a final sample of 70 patients (69%). We compared the PROMIS against region- and condition-specific PROMs in terms of responsiveness and concurrent validity. Responsiveness was determined using Cohen's d or the effect-size index (ESI). The larger the absolute value of the ESI, the greater the effect size. Using the ESI allows surgeons to better quantify the impact of CTR, with a medium ESI (that is, 0.5) representing a visible clinical change to a careful observer. Concurrent validity was determined using Spearman's correlation coefficient with correlation strengths categorized as excellent (> 0.7), excellent-good (0.61-0.70), good (0.4-0.6), and poor (< 0.4). Significance was set a priori at p < 0.05.
Among PROMIS domains, the PI demonstrated the best responsiveness (ESI = 0.74; 95% CI, 0.39-1.08), followed by the UE (ESI = -0.66; 95% CI, -1.00 to -0.31). For the MHQ, the Satisfaction domain had the largest effect size (ESI = -1.48; 95% CI, -1.85 to -1.09), while for the BCTQ, the Symptom Severity domain had the best responsiveness (ESI = 1.54; 95% CI, 1.14-1.91). The PROMIS UE and PI domains demonstrated excellent-good to excellent correlations to the total MHQ and BCTQ-Functional Status scores (preoperative UE to MHQ: ρ = 0.68; PI to MHQ: ρ = 0.74; UE to BCTQ-Functional Status: ρ = 0.74; PI to BCTQ-Functional Status: ρ = 0.67; all p < 0.001), while the PROMIS PF demonstrated poor correlations with the same domains (preoperative PF to MHQ; ρ = 0.33; UE to BCTQ-Functional Status: ρ = 0.39; both p < 0.01).
The PROMIS UE and PI domains demonstrated slightly worse responsiveness than the MHQ and BCTQ domains that was nonetheless acceptable. The PROMIS PF domain was unresponsive. All three PROMIS domains correlated with the MHQ and BCTQ, but the PROMIS UE and PI domains had notably stronger correlations to the MHQ and BCTQ domains than the PF domain did. We feel that the PROMIS UE and PI can be used to evaluate the clinical outcomes of patients undergoing CTR, while also providing more robust insight into overall health status because they are general PROMs. However, we do not recommend the PROMIS PF for evaluating patients undergoing CTR.
Level II, diagnostic study.
患者报告结局测量信息系统（PROMIS）在矫形外科中仍然是一种重要的通用患者报告结局测量（PROM）。然而，人们担心 PROMIS 作为手部手术的一般健康问卷的表现，与区域和特定条件的 PROM 相比，例如密歇根手部问卷（MHQ）和波士顿腕管问卷（BCTQ）。为了确保 PROMIS 域能够以与区域和特定条件的 PROM 相同的程度捕捉患者报告的结果，比较 PROM 的表现是必要的。
问题/目的：（1）哪些 PROM 在接受腕管松解术（CTR）的患者中表现出高反应性？（2）PROMIS 域（身体功能[PF]、上肢[UE]和疼痛干扰[PI]）中的哪些域与 HHQ 和 BCTQ 域具有同时有效性？
在这项前瞻性研究中，2014 年 11 月至 2016 年 10 月期间，一位单一外科医生选择接受 CTR 的腕管综合征患者在每次就诊时完成 BCTQ、MHQ 和 PROMIS UE、PF 和 PI 域。共有 101 名患者同意参加。其中，31 名患者（31%）在至少 6 周后未返回进行随访，被排除在外，最终样本为 70 名患者（69%）。我们比较了 PROMIS 与区域和特定条件的 PROM 在反应性和同时有效性方面的表现。反应性是通过科恩氏 d 或效应大小指数（ESI）来确定的。ESI 的绝对值越大，效果大小越大。使用 ESI 可以使外科医生更好地量化 CTR 的影响，中等 ESI（即 0.5）代表对仔细观察者的可见临床变化。同时有效性是通过 Spearman 相关系数来确定的，相关强度分为极好（>0.7）、极好-好（0.61-0.70）、好（0.4-0.6）和差（<0.4）。预先设定了显著性水平为 p < 0.05。
在 PROMIS 域中，PI 表现出最好的反应性（ESI = 0.74；95%CI，0.39-1.08），其次是 UE（ESI = -0.66；95%CI，-1.00 至-0.31）。对于 MHQ，满意度域具有最大的效果量（ESI = -1.48；95%CI，-1.85 至-1.09），而对于 BCTQ，症状严重度域具有最好的反应性（ESI = 1.54；95%CI，1.14-1.91）。PROMIS UE 和 PI 域与 MHQ 和 BCTQ-功能状态总分具有极好-好到极好的相关性（术前 UE 与 MHQ：ρ=0.68；PI 与 MHQ：ρ=0.74；UE 与 BCTQ-功能状态：ρ=0.74；PI 与 BCTQ-功能状态：ρ=0.67；均 p<0.001），而 PROMIS PF 与相同域的相关性较差（术前 PF 与 MHQ：ρ=0.33；UE 与 BCTQ-功能状态：ρ=0.39；均 p<0.01）。
PROMIS UE 和 PI 域的反应性略低于 MHQ 和 BCTQ 域，但仍可接受。PROMIS PF 域没有反应。所有三个 PROMIS 域都与 MHQ 和 BCTQ 相关，但 PROMIS UE 和 PI 域与 MHQ 和 BCTQ 域的相关性明显强于 PF 域。我们认为，PROMIS UE 和 PI 可用于评估接受 CTR 的患者的临床结果，同时提供更全面的健康状况洞察，因为它们是一般的 PROM。然而，我们不建议使用 PROMIS PF 来评估接受 CTR 的患者。
II 级，诊断研究。
